COUNCIL OF STATE AND TERRITORIAL EPIDEMIOLOGISTS BIOMONITORING IN PUBLIC HEALTH: Epidemiologic Guidance for State, Local, and Tribal Public Health Agencies TABLE OF CONTENTS Acknowledgments 5 About these Guidelines 6 Introduction 7 Planning a Biomonitoring Project or Program 9 State Statutes, Administrative Rules, Legislative Directives, Funding Sources . 10 Establishment of Goals and Objectives . 11. Selection of Target Population . 12 . Selection of Chemical Analytes . 13. Planning for Collection of Biospecimens . .14 . Planning for Other Data-Collection Activities and Instruments . 16. Identification of Stakeholders and Partners . 18 . Community Engagement . .19 . Protocol Development . 20. Ethical Considerations . 22 Implementing a Biomonitoring Project or Program 25 Data Management . 26 Biospecimen Collection . 26 Laboratory Analysis . 27 . Statistical Analysis . .27 . Results Interpretation: Methods and Comparisons . 28 Communicating Biomonitoring Results 33 Using Biomonitoring to Inform Public Health Action 39 Future Challenges 43 References 44 Appendices 47 Biomonitoring in Public Health: Epidemiologic Guidance for State, Local, and Tribal Public Health Agencies | 3 ACKNOWLEDGMENTS The development of these guidelines has been the collaborative effort of a working group of the Council of State and Territorial Epidemiologists’ (CSTE’s) Environmental Health Subcommittee and the Association of Public Health Laboratories (APHL) . CSTE is grateful to those state-based epidemiologists forming the working group for sharing their expertise and for their time in writing and reviewing this document . CSTE would like to acknowledge the following contributing authors: Rupali Das Henry Anderson California Department of Public Health Wisconsin Department of Health and Family Services Jean Johnson Minnesota Department of Health Juliet Van Eenwyk Washington State Department of Health Adrienne Kari Minnesota Department of Health Sujata Joshi Oregon Health Authority Diana Lee California Department of Public Health Erik Svendsen Tulane University School of Public Health and Kristen Malecki Tropical Medicine University of Wisconsin-Madison School of Medicine and Public Health Barbara Malczewska-Toth New Mexico Department of Health Elizabeth Lewis-Michl New York State Department of Health Erin Simms Council of State and Territorial Epidemiologists Deanna Scher Minnesota Department of Health This publication was supported by Cooperative Agreement Number 5U38HM000414 from CDC . Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC . Biomonitoring in Public Health: Epidemiologic Guidance for State, Local, and Tribal Public Health Agencies | 5 ABOUT THESE GUIDELINES In March 2010, the Association of Public Health Laboratories (APHL) requested assistance from the Council of State and Territorial Epidemiologists (CSTE) in building a national state-based biomonitoring system . APHL recognized that an effective national biomonitoring system requires a variety of skills and expertise and an infrastructure beyond those of the laboratory . These include epidemiologic aspects of conducting biomonitoring activities, such as study design, sample collection, and data analysis, and interpreting and communicating results . These guidelines were developed collaboratively by a subcommittee of the CSTE Occupational and Environmental Health Committee in response to APHL’s request . The subcommittee brought together state epidemiologists who have a broad range of biomonitoring experiences, from conducting projects to designing state programs . The guidelines are intended to assist with biomonitoring activities, sometimes referred to as “programs” if they are ongoing and “studies,” “projects” or “investigations” if they are episodic . These activities may be conducted for ongoing surveillance, epidemiologic investigation, and rapid response to protect public health . They are not intended to describe hypothesis-based research typically conducted by academic institutions . Epidemiologists, laboratorians, environmental health specialists, and others in state, territorial, tribal, and local health agencies may find these guidelines helpful in implementing biomonitoring programs and projects to inform public health decision making and actions . 6 | Biomonitoring in Public Health: Epidemiologic Guidance for State, Local, and Tribal Public Health Agencies INTRODUCTION The Centers for Disease Control and Prevention (CDC) defines biomonitoring as the direct measurement of chemical contaminants in human specimens . The ability of public health laboratories to use biomonitoring to assess human exposure to environmental chemicals has steadily advanced during the past 30 years . Today, through its National Biomonitoring Program, the CDC Environmental Health Laboratory monitors on a regular basis (every two years) the US population’s exposure to an increasing number of chemicals (currently more than 300) . As public health laboratory scientists have developed and validated new analytical methods to measure internal doses of chemicals, the numbers of health research studies and public health or epidemiologic investigations that include biomonitoring have correspondingly accelerated . Research institutions now incorporate biomonitoring into major epidemiologic studies . For example, biomonitoring is a major component of the National Institute of Child Health and Human Development’s National Children’s Study . However, state, territorial, tribal, and local public health agencies are just beginning to apply biomonitoring information and technology to environmental public health practice and disease prevention . The National Health and Nutrition Examination Survey (NHANES), which is used to collect specimens for the National Biomonitoring Program, does not allow for state- or local-level calculations of population exposure estimates . Yet, local concerns about chemical exposures continue to fuel public interest in biomonitoring, and some state legislatures have adopted legislation [1] to encourage or require state agencies to conduct biomonitoring at the state and local levels . As researchers and communities learn more about biomonitoring, the demand for this exposure measurement tool in public health settings is expected to grow . In 2002, CDC began to fund planning and implementation grants to build biomonitoring capacity in state public health laboratories . In 2009, three states (California, New York, and Washington) were awarded funds to increase biomonitoring capability and capacity in their public health laboratories . This support will enhance the capability and capacity of these states to assess human exposure to environmental chemicals within their jurisdictions . Biomonitoring in a public health context poses a number of challenges . These include study design and implementation, as well as ethical concerns, and unique methodologic issues that have yet to be fully appreciated . Understanding public perceptions and developing effective methods for communicating and interpreting results remain areas of interest and active research . According to the National Research Council’s Committee on Human Biomonitoring for Environmental Toxicants, one of the greatest challenges “for public health agencies is to understand the health implications of the biomonitoring data and to craft appropriate public health responses” [2] . Biomonitoring in Public Health: Epidemiologic Guidance for State, Local, and Tribal Public Health Agencies | 7 INTRODUCTION These guidelines provide information about and help to guide decisions by public health officials and scientists about the design, conduct, interpretation, and application of biomonitoring activities . They address the major components for planning and implementing biomonitoring in a public health setting, including engaging stakeholders, developing protocols, addressing ethical considerations, selecting biomarkers, collecting biospecimens and other data, analyzing and displaying data, interpreting and communicating results, and using the findings to support public health action . A checklist of the key steps to developing a biomonitoring program or project appears at the end of this document (Appendix III) . Along with state partners, CSTE hopes to build a foundation for biomonitoring that is scientifically rigorous, has broad public acceptance and support, and ultimately will best enable crafting appropriate public health responses to potential health effects of chemicals in our environment and our bodies . 8 | Biomonitoring in Public Health: Epidemiologic Guidance for State, Local, and Tribal Public Health Agencies PLANNING A BIOMONITORING PROJECT OR PROGRAM PLANNING A BIOMONITORING PROJECT OR PROGRAM Setting priorities and uniform policies a priori Center for Environmental Health, Agency for is essential to guide planning decisions for Toxic Substances and Disease Registry), the biomonitoring programs and projects . Statutory National Institutes of Health (National Institute authority may dictate many elements of a public of Environmental Health Sciences), and health biomonitoring program . Other essential nongovernment foundations . elements to consider during planning include establishing program goals and objectives; Most states have mandatory disease reporting selecting the target population and chemical rules that may already include reporting of analytes; establishing methods for collecting diseases that consider environmental chemical biospecimens and epidemiologic